Cardiac ventricular geometry restoration device and treatment for heart failure

Abstract

Methods for cardiac ventricular restoration include delivering an implantable expandable device into the ventricle via a catheter. The expandable device is anchored either to the wall of the left ventricle or to the inter-ventricular septum and then expanded. When expanded, the device assumes a size and shape which fills the lower portion of the ventricular cavity restoring the normal volume and ellipsoid shape of the remaining portion of the cavity and favorably altering myocardial oxygen demand and wall stress.

1. An apparatus for percutaneous cardiac ventricular restoration, comprising:
 a balloon constructed in size and shape which permit said balloon to be delivered percutaneously to an interior of a ventricle in an unexpanded state, and expanded into an expanded state once said balloon has been delivered to the interior of the ventricle; 
 a basket integrated with said balloon, said basket adapted to apply an expansion force to said balloon to bias said balloon into said expanded state; and 
 an anchoring device coupled to said balloon, said anchoring device adapted to anchor said balloon to a ventricular apex without coupling said balloon to a ventricular septum or a ventricular wall. 
 
     
     
       2. An apparatus according to  claim 1 , wherein:
 said balloon includes a longitudinal axis, and said anchoring device is provided along said longitudinal axis. 
 
     
     
       3. An apparatus according to  claim 1 , further comprising:
 a delivery device having structure which permits it to deliver said balloon in the unexpanded state percutaneously through a blood vessel to the interior of the ventricle. 
 
     
     
       4. An apparatus according to  claim 3 , wherein:
 said delivery device includes a distal end, said basket is coupled to said distal end of said delivery device, and said delivery device is operable to expand said basket and release said basket from said distal end of said delivery device. 
 
     
     
       5. An apparatus according to  claim 1 , wherein:
 said anchoring device is structured to penetrate at least partially through an apical wall of the heart. 
 
     
     
       6. An apparatus according to  claim 1 , wherein:
 said anchoring device is structured to penetrate completely through an apical wall of the heart. 
 
     
     
       7. An apparatus according to  claim 1 , wherein:
 said balloon is longitudinally asymmetrical when in the expanded state. 
 
     
     
       8. An apparatus according to  claim 7 , wherein:
 said balloon is rotationally asymmetrical when in the expanded state. 
 
     
     
       9. An apparatus according to  claim 1 , wherein:
 said balloon is rotationally asymmetrical when in the expanded state. 
 
     
     
       10. An apparatus according to  claim 1 , wherein:
 said basket is self-expanding to the expanded state. 
 
     
     
       11. An apparatus according to  claim 1 , wherein:
 said interior of said balloon is evacuated when said balloon is in said expanded state. 
 
     
     
       12. An apparatus for cardiac ventricular restoration of a heart having a ventricular septum, a ventricular wall and a ventricular apex therebetween, comprising:
 a delivery device having an inflation lumen, a user-operated proximal end and a distal end; 
 a rotationally asymmetrical balloon releasably coupled to said distal end of said delivery device, said balloon constructed in a size and shape which permit said balloon to be delivered to an interior of the ventricle in an unexpanded state and being constructed to permit said balloon to be expanded once said balloon has been delivered to the interior of the ventricle; 
 said balloon having a valve and a coupling device, said coupling device for attachment relative to said inflation lumen for inflating said balloon, and said valve automatically closing to seal said balloon in a fluid-tight manner when said balloon is uncoupled from said distal end of said delivery device; and 
 an anchoring device coupled to said balloon and having structure adapted to anchor said balloon to the ventricular apex, such that when said delivery device releases said balloon at the interior of the ventricle and said anchoring device is anchored to the ventricular apex, said balloon remains anchored within the ventricle with said valve sealing said balloon in the fluid-tight manner. 
 
     
     
       13. An apparatus according to  claim 12 , wherein:
 said structure of said anchoring device anchors said balloon to the ventricular apex without anchoring said balloon to a ventricular septum or ventricular wall. 
 
     
     
       14. An apparatus according to  claim 12 , wherein:
 said balloon in an unexpanded state is sized to be delivered percutaneously into the heart. 
 
     
     
       15. An apparatus for cardiac ventricular restoration of a heart having a ventricular septum, a ventricular wall and a ventricular apex therebetween, comprising:
 an asymmetrical balloon constructed in a size and shape which permit said balloon to be delivered percutaneously to an interior of the ventricle in an unexpanded state and being constructed to permit said balloon to be expanded once said balloon has been delivered to the interior of the ventricle; 
 an expandable basket to expand the balloon after said balloon is in the interior of the ventricle; 
 a delivery device having a distal end to which said balloon is releasably coupled, said delivery device able to deliver said balloon in the unexpanded state percutaneously to the ventricular apex; and 
 an anchoring device coupled to said balloon and having structure adapted to anchor said balloon to the interior of the ventricle at the ventricular apex, 
 wherein once said balloon is anchored, said delivery device can be operated to release said balloon from said distal end of said delivery device. 
 
     
     
       16. An apparatus according to  claim 15 , wherein:
 said structure of said anchoring device permits said balloon to be anchored at the ventricular apex without being anchored to the ventricular septum or the ventricular wall. 
 
     
     
       17. An apparatus for percutaneous cardiac ventricular restoration, comprising:
 a balloon having an interior and constructed in size and shape which permit said balloon to be delivered percutaneously to an interior of a ventricle in an unexpanded state, and expanded into an expanded state once said balloon has been delivered to the interior of the ventricle, said balloon being evacuated of fluid at said interior of said balloon when in the expanded state; and 
 an anchoring device coupled to said balloon and having structure adapted to anchor said balloon to a ventricular apex without coupling said balloon to a ventricular septum or a ventricular wall. 
 
     
     
       18. An apparatus according to  claim 17 , further comprising:
 a delivery device having structure which is adapted to deliver said balloon in said unexpanded state percutaneously through a blood vessel to the interior of the ventricle.